AM-101

Thank you. Do you have any other information about these clinicals?

 

Even if they do, I suspect they will only find a tiny subset of people with T that their drug helps. From what I read on this forum, very few of our members who tried it had any improvement and for a bunch of people things got much worse.

 

It's been a month since my noise exposure (probably) caused a mild form of T (with all the ups and downs, I've bothered everyone with.) Since it's still fairly recent there is a chance this medicine will work, but I am too afraid to let my T, which I can and will cope with eventually , worsen because of the experimental medicine.

Anyone here used AM-101? Any results?

(On the other hand, as many members stated, I'll encounter much more unavoidable loud noise, so I am also afraid that the T I have now will worsen whatsoever, and this might be a way too compensate future damage?)

 

Poor, poor results. A small group has seen improvements, others nothing. Good as placebo.

Can you get in the trial?

 

Yeah, perhaps. I have an intake meeting this Friday.

 

So are there lots of patients with worsened, symptoms? I know I asked this before, but trying to get as many opinions as possible.

 

Buddy are you lazy or what, why don't you do your own research and read the study results from the phase 2 and first phase 3 trials, you can find links from Auris Medical's site or on google. The incidence of side effects is minimal. It's a safe procedure and treatment. It probably won't do anything for your tinnitus, good or bad.

 

I've been reading anything I can find, thanks for your concern. Just trying to find out anything "new". Or someone who is in the same situation. I have a feeling it will probably do nothing for me, but you can only know by trying I guess. If they let me in, ofcourse.

 

Yes someone here had a really bad worsening. He only had mild T which increased tremendously, became reactive and got H.
The study results for noise trauma show literally 0 improvements in T

 

If you do, make sure they use phenol and not lidocaine and ask if they can not suction it out. I have a feeling some of the worsenings were caused by the suctioning.

Source on this?

 

Their PowerPoint presentation of the results. It's posted somewhere in the forum I think it was by ATEOS in the experience thread in the treatment section

 

Already regret signing up.
Good that I can cancel the injections, maybe I shouldn't even go to the intake, don't want to waste their time.
I don't get why they are continuing the clinical trials, which, apparently, such results?
Is there a possibility they changed something about the drugs in phase 3? Delivery method, timing, amount?

 

They are continuing because the drug showed good results for T from otitis media. Also they said that they had bad result on other causes because of the design of the trial but I don't think that's really the case...

 

With bad results: I suppose you mean. "No positive or negative chance."?

 

Yes no change in T

 

Probably because of the timing, and other things I've already mentioned. The window of opportunity is likely much shorter, and that's assuming the noise damage that caused tinnitus is acute and not accumulative which is often not the case.

 

Oh, the more I read. I am pretty sure my damage is also accumulative, the "initial" shock was nowhere strong enough to cause T on its own, I believe. And since I already had some haircell-damage (As measured by an OEA some weeks before) ...

Sorry, not trying to hijack this topic.
Anyway In two hours I have the intake-conversation, I just hope they are not going to suggest to do the injection immediately .

 

So I went, fantastic team here in UZ-Gent Belgium. They were very open for all my questions, took all time necessary, zero pressure whatsoever (which is to be expected), all around good experience.

I have to keep a log from now on, for two weeks, when the injections are planned. So I still have time to change my mind. Even though I feel pretty sure about the all-around safety now.

I feel a bit worse because I had to a new hearing-test, which is kinda painful, it's the most silent room I've ever been in, and my T was going mad in the end. Even though I don't really hear it in the daily life.
Scary to know that "that" is the 'baseline'.

Furthermore, apparently there will be suction. She demonstrated this with the smallest & most quiet they have. It felt pretty "loud" but doable. I do fear this the most..

 

Damnit, they called me back: apparently they can't enroll me. Since in my initial report I talked about T in both ears (while twice or trice as loud in the other ear, and almost in audible in one.)
And they are only enrolling people with T in one ear..

 

Would you have said you have tinnitus in only one ear if you had known about it?

 

Well, I don't wanna screw up trial-results. So I'd probably be too honest for this world.

 

http://www.dailymail.co.uk/health/article-1197912/How-jab-ear-banish-tinnitus-good.html

 

It's AM-101.........

 

https://www.ncbi.nlm.nih.gov/pubmed/24603353

RESULTS:
The study overall failed to demonstrate a treatment benefit based on the change in MML. However, AM-101 0.81 mg/ml showed statistically significantly better improvement for tinnitus loudness, annoyance, sleep difficulties, and tinnitus impact in patients with tinnitus

No cure. Minimum masking level didn't improve at all. Just subjectively people with AM-101 injections said it was better than the placebo injections. 60% of the placebo group said that there was an improvement according to figure 2. 75% said it was an improvement for those who got AM-101 and more of them said it was a much bigger improvement. This could be a treatment since it does show minor improvement coping with tinnitus, sleeping, etc... There needs to be a lot bigger sample size though.

Almost every placebo group in tinnitus study say that there is a 40%-50% improvement. It just shows you how important a control group is.

 

Only regenerative medicine will work. Auris Medical seems far behind others now...